Trials / Completed
CompletedNCT03969797
AED Log Analysis of 19 Cases in Out-of-hospital Environment
Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment: a Prospective Randomized Log Analysis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- RadianQbio · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment.
Detailed description
The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer. The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RADIAQBIO Heart Guardian HR-501 | Arm one offers ECG data and electric shocks recorded during AED operation. |
Timeline
- Start date
- 2016-03-25
- Primary completion
- 2018-10-08
- Completion
- 2019-01-15
- First posted
- 2019-05-31
- Last updated
- 2019-05-31
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03969797. Inclusion in this directory is not an endorsement.